Registration Dossier
Registration Dossier
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EC number: 202-815-9 | CAS number: 100-06-1
Endpoint summary
Administrative data
Description of key information
Oral: The LD50 value of the test material was established to be 1720 mg/kg bw.
Dermal: The acute dermal toxicity study with 5000 mg/kg bw of the test substance caused no mortality in rabbits and therefore a LD50 of > 5000 mg/kg bw was derived.
Inhalation: A study was scientifically not necessary since data for two other routes are available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975-07-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- according to an internal method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 1050, 1640, 2050, 2560 and 5000 mg/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- no
- Details on study design:
- not specified
- Statistics:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 720 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.47 - <= 1.97
- Clinical signs:
- other: At the 5000 mg/kg bw level: lethargy, urinary incontinence, piloerection At lower doses: none
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In the acute oral toxicity study with doses of 1050, 1640, 2050, 2560 and 5000 mg/kg bw of the test substance, a LD50 of 1720 mg/kg bw was derived.
- Executive summary:
In an orale acute toxicity study, 50 rats were orally exposed once with the test substance at concentrations of 1050, 1640, 2050, 2560 and 5000 mg/kg bw and were observed for a period of 14 days (similar to OECD 401). The LD50 value of the test material was established to be 1720 mg/kg bw.
Reference
Table: Distrubution of mortality
Dose [g/kg] |
Deaths/No. of animals |
Observation Day |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1.05 |
2/10 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.64 |
2/10 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2.05 |
6/10 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2.56 |
10/10 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5.00 |
10/10 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 720 mg/kg bw
- Quality of whole database:
- Experimental study similar to OECD guideline 401.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975-07-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- according to an internal method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- not specified
- Duration of exposure:
- 14 days
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals (sex not specified)
- Control animals:
- no
- Details on study design:
- not available
- Statistics:
- not specified
- Preliminary study:
- Not performed.
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none (0/10 animals)
- Clinical signs:
- other: not recorded
- Gross pathology:
- Slight redness - 1/10 animals
Moderate redness - 9/10 animals
Slight edema - 3/10 animals
Moderate edema - 7/10 animals - Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity study with 5000 mg/kg bw of the test substance caused no mortality in rabbits and therefore a LD50 of > 5000 mg/kg bw was derived.
- Executive summary:
In an acute toxicity study, 10 rabbits were dermally exposed once with the test substance at a single dose of 5000 mg/kg bw and were observed for a period of 14 days (similar to OECD 402). No mortallity was observed during the test. The LD50 value of the test material was established to be > 5000 mg/kg bw.
Reference
Table: Results on mortality
Dose [g/kg]
|
Deaths/No. of animals
|
Observation Day |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
5 |
0/10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Experimental study similar to OECD guideline 402.
Additional information
Acute toxicity: oral
In an orale acute toxicity study (1973), 50 rats were orally exposed once with the test substance at concentrations of 1.05, 1.64, 2.05, 2.56 and 5.00 g/kg bw and were observed for a period of 14 days (similar to OECD 401). The LD50 value of the test material was established to be 1720 mg/kg bw.
Acute toxicity: inhalation
The study does not need to be conducted because data for two other routes are available.
Acute toxicity: dermal
In an acute toxicity study (1973), 10 rabbits were dermally exposed once with the test substance at a single dose of 5.00 g/kg bw and were observed for a period of 14 days (similar to OECD 402). No mortallity was observed during the test. The LD50 value of the test material was established to be > 5000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral and dermal route, the test item is to be classified in category 4 according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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